PFO, migraine, closure Foramen ovale persistens, migraine, sluiting
Conditions
Interventions
In migraine patients with aura who have a patent foramen ovale, transcatheter device closure PFO after randomization will be performed or sham procedure
Sponsors
St Jude Medical inc
The corporate village 11- box F1
B-1935 Zaventem
Belgium
0032 27746937
Coordinating clinical investigators: Prof MD Ferrari, Neurology department LUMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Migraine with aura; 2. Migraine history of at least 1 year at least 2 migraine attacks/month at least 1 migraine attack with aura; 3. Failure or intolerance to 2 classes prophylactic migraine medication; 4. Aged 18-50; 5. Right to left shunt suitable for closure.
Exclusion criteria
Exclusion criteria: 1. History of 15 or more headache days per month; 2. Taking preventive medication for other conditions other than migraine; 3. 8 or more non-migraine headache days/month; 4. Overuse of acute headache medication( use on 10 or more days/month; 5. Severe central nervous system disease previous surgical or device closure of PFO/ASD; 6. Atrial heart valve; 7. Pacemaker or ICD implanted within past 3 months; 8. History of atrial fibrillation; 9. Undergoing dialysis; 10. NYHA class 3 or 4 cardiac failure; 11. Pregnant; 12. Anticoagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing 50% reduction of migraine in closure group compared with sham group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean values of monthly migraine periods QoL using headache impact test questionaire. | — |
Contacts
Public ContactH. Koppen
Leiden University Medical Center (LUMC), Department of Neurology Postbus 9600
Outcome results
None listed